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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005289-20 | EudraCT Number | ||
| INDIGOAPS1003 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to gather information about the steady-state plasma concentrations of aripiprazole, olanzapine, quetiapine and their relevant metabolites, at various dose levels and at different time points after dosing. In addition, comparison of capillary drug concentrations vs. venous drug concentrations will be performed for aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and their relevant metabolites.
This is an open-label (physicians and participants know the identity of the assigned treatment), parallel-group, multiple-dose, multicenter study to assess pharmacokinetics (what the body does to the medication) of five antipsychotics (APS) drugs: aripiprazole, olanzapine, paliperidone, quetiapine and risperidone in psychiatric participants who are receiving stable doses of these drugs for the treatment of their disease.
Pharmacokinetics data will be generated from venous and fingerstick-based capillary plasma concentrations of the drugs and their metabolites. The total number of enrolled participants in this study will be at least 265. Seventy-five participants will be enrolled for the aripiprazole, olanzapine and quetiapine cohorts (groups) each, and 20 participants will be enrolled for the paliperidone and risperidone cohorts each. In aripiprazole, olanzapine and quetiapine cohorts there will be two subgroups. Subgroup one, 20 participants for fingerstick capillary + venous blood sampling and subgroup two, 55 participants for only venous sampling. Paliperidone and risperidone cohorts will be subjected only to capillary + venous blood sampling.
The study will consist of a screening phase (within 21 days before Day 1) followed by a 3-day observation phase (Day 1 to Day 3). Participants will be admitted to the study center in the evening of Day -1 and will remain in the study center until discharged on Day 3 after completion of the last study-related procedure. During the observation phase, the administration of the prior antipsychotic medication will continue at a participant's usual dose and dosing schedule, under direct observation of the study staff. There will be no modification of the participant's medication during the study. Safety will be evaluated throughout the study and a mandatory pharmacogenomic blood sample will be collected for analysis of genes that may influence exposure of the APS studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Aripiprazole | Experimental | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. |
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| Cohort B: Olanzapine | Experimental | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. |
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| Cohort C: Paliperidone | Experimental | Administration of prolonged-release (extended-release) tablets or long-acting injectables (LAI) will continue at a participant's usual dose and dosing schedule. |
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| Cohort D: Quetiapine | Experimental | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. |
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| Cohort E: Risperidone | Experimental | Administration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole, oral formulation | Drug | Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications. |
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| Measure | Description | Time Frame |
|---|---|---|
| Aripiprazole concentration in venous and capillary plasma | Venous blood samples will be collected at 8 scheduled time points after dosing and compared to fingerstick-based capillary blood samples collected at 6 scheduled time points after dosing. | 14 time points over 3 days postdose |
| Paliperidone concentration in venous and capillary plasma | 14 time points over 3 days postdose | |
| Olanzapine concentration in venous and capillary plasma | 14 time points over 3 days postdose | |
| Quetiapine concentration in venous and capillary plasma | 14 time points over 3 days postdose | |
| Risperidone concentration in venous and capillary plasma | 14 time points over 3 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with an adverse event as a measure of safety | Participants will be followed for the duration of hospital stay, an expected average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garden Grove | California | United States | ||||
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| Label | URL |
|---|---|
| Open-Label Pharmacokinetic Study to Evaluate the Steady-State Venous and Capillary Plasma Concentrations of 5 Antipsychotics: Aripiprazole, Olanzapine, Paliperidone, Quetiapine and Risperidone | View source |
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| Olanzapine, oral formulation | Drug | Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications. |
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| Paliperidone, oral formulation | Drug | Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications. |
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| Paliperidone, LAI | Drug | Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications. |
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| Quetiapine, oral formulation | Drug | Quetiapine immediate-release (IR) formulation or extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications. |
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| Risperidone, oral formulation | Drug | Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications. |
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| Risperidone, LAI | Drug | Risperidone LAI injections will be administered will be administered per the locally approved label indications. |
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| Kissimmee |
| Florida |
| United States |
| Atlanta | Georgia | United States |
| Hoffman Estates | Illinois | United States |
| Cedarhurst | New York | United States |
| Austin | Texas | United States |
| Banfield | Argentina |
| Buenos Aires | Argentina |
| Córdoba | Argentina |
| La Plata | Argentina |
| Aalst | Belgium |
| Antwerp | Belgium |
| Brussels | Belgium |
| Kortenberg | Belgium |
| Rio de Janeiro | Brazil |
| Valinhos | Brazil |
| Burgas | Bulgaria |
| Berlin | Germany |
| Hamburg | Germany |
| Lübeck | Germany |
| Badajoz | Spain |
| Barcelona | Spain |
| Torrevieja | Spain |
| Zamora | Spain |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D004304 | Dosage Forms |
| D000077152 | Olanzapine |
| D000068882 | Paliperidone Palmitate |
| D000069348 | Quetiapine Fumarate |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D011743 | Pyrimidines |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011744 | Pyrimidinones |
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